Responsible for preclinical safety assessment, including toxicology, pathology, drug metabolism, bioanalytics, and pharmacokinetics/toxicokinetics. Set policy and directed strategic planning for all non-clinical safety testing of new and marketed products, led day-to-day operations, set safety standards and assessments of potential new molecular entities, and managed study outsourcing activities. Provided advice to global drug development teams and assessed acceptability of new submissions to worldwide health authorities. Guided global drug development teams on strategies, problem resolution, and health authority requests (i.e., Taspoglutide). Coordinated preclinical development activities for therapeutic stem cell therapy program and developed strategy for sustainable nonclinical Safety Capacity in Africa with WHO.

Provided advice, feedback, and support to head of Global Safety, and regulatory advice to early- and late- stage projects. Advised drug development teams and assessed acceptability of new submissions to FDA. Interacted with US DRA to preview submissions, acted as mock FDA reviewer, and provided nonclinical advice. Guided drug development teams on strategies, problem resolution, and health authority requests. Developed and implemented cohesive CRO strategy and established partnership.

Led Preclinical Development. Provided oversight of all biology functions and development activities required for the successful submission of dossiers for new and reformulated products. Enhanced interactions with Discovery Research to better select development candidates.